Quick summary
Quick summary: Vivos Guides. Date: 2025-08-07.
Public recall detail
Vivos Guides
2025-08-07
Recall
Safety notice
Recommended action
Recommended action: compare your product with the official notice and follow the instructions published by the official source.
Recall details
Quick summary: Vivos Guides. Date: 2025-08-07.
Official details
Affected product details
Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.
BrandVivos Therapeutics, Inc.
ProductVivos Guides
IssueMedical devices - Unauthorised device
Recall classType II
IdentificationRA-77812
Affected products
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0003 : GUID0003-KIDS-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0003 : GUID0003-KIDS-PIN
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-45-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-50-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-50-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-65-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0003 : GUID0003-KIDS-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0003 : GUID0003-VSTR-PUR
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-25-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-30-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-40-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-60-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-65-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0006 : GUID0006-35-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0008 : GUID0008-PUR
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-30-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-35-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-35-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-40-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-60-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0006 : GUID0006-40-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0006 : GUID0006-50-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0003 : GUID0003-VSTR-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-25-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-30-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-40-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-50-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-70-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-55-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-55-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-70-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0006 : GUID0006-70-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-35-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-45-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-25-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-55-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0006 : GUID0006-65-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-45-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0006 : GUID0006-70-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0008 : GUID0008-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0008 : GUID0008-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0003 : GUID0003-KIDS-PUR
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0003 : GUID0003-VSTR-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0003 : GUID0003-VSTR-PIN
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-35-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0004 : GUID0004-65-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0005 : GUID0005-45-CLE
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0006 : GUID0006-30-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0006 : GUID0006-45-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
ProductVivos Guides
LotMore than 10 numbers, contact manufacturer.
ModelGUID0006 : GUID0006-55-BLU
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVivos Guides
Issue
This recall submission is due to a difference in classification of 1 types of devices; both were originally inputted as Class 1 but after an audit review, the devices are determined to be Class 2 through the audit inspection, and therefore the manufacturer is stopping sale of these device, the Vivos Guides and the Vivos Pex. Recall start date: June 9, 2025
What you should do
- Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public
CategoryHealth products - Medical devices - Dental
CompaniesVivos Therapeutics, Inc. 7921 Southpark Plaza, Littleton, Colorado, United States, 80120
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-77812
Background{}
CompaniesVivos Therapeutics, Inc. 7921 Southpark Plaza, Littleton, Colorado, United States, 80120
AudiencesGeneral public
Source updated2025-08-07
Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.
FAQ
Frequently asked questions
Answers based on the official recall notice.
Product images
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